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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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OSB Lead-PAS of MelaFind


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General
Application Number P090012 / PAS001
Current Plan Approved 10/22/2014
Study Name OSB Lead-PAS of MelaFind
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Analytical
Study Population Adolescent: 13-18 yrs, Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description This is a multicenter, prospective, observational, single arm, post-

approval study of MelaFind, which will enroll lesions that meet the labeled Indications for Use. Dermatologists┬┐ biopsy decisions before and after obtaining MelaFind results will be recorded. Biopsy specimens will undergo central dermatopathology review to determine whether the lesion is melanoma, high-grade, or another type of lesion. Patient follow- up will extend out to 24 months.

Study Population Description All patients of any age, race, ethnicity, or gender, presenting with pigmented skin lesions that meet the Indications for Use and lesion Inclusion and Exclusion Criteria, including signing the Informed Consent

Form, are eligible to participate in this study.

Up to six clinical sites in the US will participate in this study. Three of the sites will be located in urban settings, and three will be located in a suburban or rural setting. At least 50% of the sites will be new, i.e., they did not participate in the MelaFind pivotal study. Some sites will be academic centers and some private practices.

Sample Size It is anticipated that at least 78 patients with one or more eligible and evaluable histologically-confirmed melanoma and or high-grade lesion will be enrolled.A total of 720 patients and a total number of lesions to range from 720 up to about 3600 are expected to be enrolled in the study.
Data Collection The primary objective of this study to test the hypothesis that, among eligible and evaluable lesions with central histological reference

standard status melanoma or high-grade lesion, the relative sensitivity ├▒ comparing enrolling dermatologists after MelaFind use with enrolling dermatologists if MelaFind were not available is greater than 110%..



Secondary Objectives

Real-World Use of MelaFind

1. To describe characteristics of patients with lesions imaged with

MelaFind, including age, gender, race, ethnicity, and Fitzpatrick skin type

2. To describe characteristics of lesions imaged with MelaFind, particularly the proportion of such lesions that meet the labeled Indications for Use

3. To describe the experience oF/Using MelaFind to image lesions, particularly:

a. Number of imaging attempts

b. Proportion of lesions for which an image that passes automatic

image QC algorithms is not obtained (non-evaluables)

4. To describe the distribution of MelaFind test results (positive, negative) among lesions with images that pass automatic image QC algorithms



Safety and Effectiveness of MelaFind

5. To describe the proportion of lesions that are biopsied among lesions with positive MelaFind test results, among lesions with negative MelaFind test results, and among non-evaluables (lesions with images that do not pass automated QC algorithms)

6. Among biopsied lesions:

a.To describe biopsy results based on central histological reference standard (melanoma, high-grade lesion [high-grade dysplastic nevus, atypical melanocytic hyperplasia proliferation], other) among lesions with positive MelaFind test results, among lesions with negative

MelaFind test results, and among non-evaluables

b. To estimate sensitivity of MelaFind to melanomas and high-grade lesions, based on central histological reference standard

c. To estimate specificity of MelaFind for non-melanomas and non-high- grade lesions, based on central histological reference standard

7. To describe lesion management decisions of dermatologists before and after MelaFind evaluations:

a. For all lesions: among non-evaluable lesions, among evaluable lesions with positive MelaFind test results, and among evaluable lesions with negative MelaFind test results

b. For eligible and evaluable lesions that are neither melanomas nor high-grade lesions: ratio of false-positive fraction (FPF) after MelaFind evaluation to FPF if MelaFind were not available.

c. For biopsied lesions: true positives, true negatives, false positives, false negatives, and biopsy ratios (number of false positives for each true positive)

d. For biopsied lesions: ratio of false-positive fraction after MelaFind evaluation to false-positive fraction if MelaFind were not available (relative false-positive fraction)

e. For biopsied lesions: ratio of biopsy ratio after MelaFind evaluation to biopsy ratio if MelaFind were not available (relative biopsy ratio)

8. Among lesions without biopsy after 2-year follow-up, describe the

results of all available MelaFind evaluations

Follow-up Visits and Length of Follow-up Patient follow-up will extend out to 24 months.

Patients with lesions evaluated with MelaFind during the enrollment period, but not biopsied at that time, will be scheduled for follow-up appointments at 1 year ┬▒3 months and 2 years ┬▒3 months. If a patient returns to the clinic for a lesion examination anytime between enrollment and the 2 year follow-up visit, per the dermatologists standard of care, follow-up visit data will be collected and

analyzed as described in the statistical analysis section.



OSB Lead-PAS of MelaFind Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 02/08/2013 02/08/2013 On Time
one year report 08/08/2013 08/08/2013 On Time
18 month report 02/08/2014 02/07/2014 On Time
two year report 08/08/2014 08/08/2014 On Time
30 month report 02/08/2015 02/06/2015 On Time
three year report 08/08/2015 07/30/2015 On Time
Final Report 03/18/2016 03/18/2016 On Time


Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov

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